Effect of Some Drugs on Rheumatoid Arithritis Activity

December 7, 2018 updated by: Sherief Abd-Elsalam

Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis

Effect of Some Drugs on Rheumatoid Arithritis Activity.

Study Overview

Status

Recruiting

Detailed Description

The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tanta, Egypt, 35111
        • Recruiting
        • Sherief Abd-Elsalam
        • Contact:
          • Fedaa Kotkata, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • liver or renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Active Comparator: Rupatadine
Rupatadine 10 mg once daily.
Rupatadine 10 mg daily
Active Comparator: Montelukast
Montelukast 10 mg daily
Montelukast 10 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
se level of IL-17
Time Frame: 6 months
change in level of IL-17
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sahar K Hegazy, Prof, Head of clinical Pharmacy Department
  • Study Director: Tarek M Mostafa, Prof, Clinical pharmacy Department- Tanta University
  • Study Chair: Salwa E Abd El-Ghany, Prof, Rheumatology Dept. - Tanta University
  • Study Chair: Fedaa AK Kotkata, Msc, Clinical pharmacy Department-Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

October 1, 2026

Study Completion (Anticipated)

October 1, 2027

Study Registration Dates

First Submitted

December 7, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

December 10, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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